Hospital-based Diabetes Prevention Study in Korea

Phase 4

• Conditions: PreDiabetes
• Interventions: Behavioral: Exercise and Diet remedies; Drug: Metformin

• Registration Number: NCT02981121
• Lead Sponsor: Jeong-taek Woo

Brief Summary

The investigators will study prevention effect of Life style modification on diabetes mellitus comparing with conventional management and Metformin administration.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-02
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-21
• Last Update Posted: 2017-07-25
• Primary Completion: 2019-11
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 744

Inclusion Criteria

1. 30<Age<71
2. BMI≥23 kg/m2
3. '75g Oral glucose tolerance 2 hours after the test Blood glucose140~199mg/dL' or 'Fasting Blood Sugar 110~125 mg/dL' or 'HbA1c 5.7%~6.4%'

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Exclusion Criteria

1. Who diagnosed with Diabetes Mellitus or Who having Drugs for Diabetes Mellitus.

2. Type 2 Diabetes Mellitus

   • Who diagnosed with Diabetes Mellitus except for maternity period.
   • Who have had drugs for Diabetes Mellitus(hypoglycemic agent or insulin) except for maternity period.
   • Fasting Glucose≥ 126 mg/dL
   • 75g Oral glucose tolerance 2 hours after the Blood glucose ≥ 200 mg/dL
   • HbA1c ≥ 6.5%

3. Who life expectancy is short.

   • Cardiac history

     • History of severe cardiovascular disease within the last 6 months (cerebral hemorrhage, stroke, myocardial infarction, angina pectoris, heart failure, etc.)
     • Systolic blood pressure >180 mmHg or Diastolic blood pressure >105 mmHg
     • aortic stenosis
     • Left bundle branch block or Third degree AV block

   • Who had been diagnosed and treated for malignant tumors including leukemia and lymphoma within the last 5 years

   • Abnormal renal function (Creatinine ≥ 1.4 mg/dL (male) or ≥ 1.3 mg/dL (female) or Urine Protein ≥ 2 +)

   • Anemia(Hematocrit <36%((male) or><33%(female)) ⑤ Cirrhosis or chronic active hepatitis (AST/ALT>３UNL)

   • Acute gastrointestinal disease (pancreatitis, infectious intestinal disease)

   • Who is scheduled major surgery within the last 3 to 6 months or just after the surgery.

   • Chronic infection (HIV, active tuberculosis, etc.)

   • Pulmonary patients who rely on oxygen or daily bronchodilators

4. Who is judged to be able to influence the clinical trial by investigator.

   • Who can not communicate
   • Those with psychiatric or cognitive impairment that may affect the compliance of the clinical trial
   • Those who do not agree to the treatment group allocation by random assignment
   • Those who participate in other studies that may interfere with the clinical trial
   • Those who lost weight by more than 10% during the past 6 months, excluding weight loss after giving birth
   • Those who can not have normal walking or exercise
   • Women who are pregnant
   • Those who are currently pregnant or who are within the last 3 months after giving birth
   • Those planning pregnancy during the clinical trial period
   • Those who have a history of drug and alcohol abuse (acute, chronic) within the last 2 years
   • Those who are not appropriate or unreliable for clinical trials at the discretion of the tester

5. Who taking medication or medical condition that may affect the diagnosis of diabetes

   • Thiazide diuretics
   • Systemic beta blockers
   • Taking Niacin for the treatment of neutropenic depression
   • Possibility of taking or injecting a systemic steroid preparation
   • Taking a serotonin reuptake inhibitor (SSRI) for weight loss purpose.
   • Taking medicine for weight loss
   • Hormone status is not appropriate during thyroid hormone replacement therapy (TSH abnormal range) (If thyroid hormone therapy is stable for more than 3 months and TSH is normal, the patient can participate in)
   • Others with other endocrine diseases (eg Cushing's syndrome, acromegaly)
   • During treatment, fasting plasma triglyceride> 600 mg / dL

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Life style modification	Exercise and Diet remedies	Proceed according to the Intervention Protocol developed by the Nutrition Committee of the Korean Diabetes Association. Aim to lose more than 5% of weight within 6 months, and then aim to keep weight loss constantly. After randomization, the diabetes educator team (physician / nurse / dietician) applies the intervention program for exercise therapy and diet therapy, and manages it through online education (telephone visit) and offline education (institution visit). * Exercise: Moderate or abnormal exercise for more than 150 minutes per week (moderate or abnormal exercise for 30 minutes or more per day) * Diet remedies: Train Calorie intake, nutrient intake and Monitoring.
Metformin	Metformin	After randomization, take 250 mg once a day for 2 weeks. If there is no side effect, take 500 mg once a day for 2 weeks. If there are no side effects, the maximum dose can be increased to 1000mg.

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of Diabetes Mellitus after randomization	36 months from the baseline	Definition of "incidence of Diabetes Mellitus"; * Fasting Glucose ≥126 mg/dL or; * 75g Oral glucose tolerance test 2 hours after the Blood glucose ≥ 200 mg / dL or; * HbA1c≥6.5%

Secondary Outcome Measures

Name	Time	Method
Change on HbA1c	12, 24, 36 months from the baseline
Change on Fasting Glucose	12, 24, 36 months from the baseline
Change on HOMA2%S	12, 24, 36 months from the baseline
Change on HOMA2%B	12, 24, 36 months from the baseline

Trial Locations

Locations (1)

Kyunghee University Medical Center; 🇰🇷 Seoul, Korea, Republic of